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Interferon + Temozolomide Active Against Advanced Melanoma: Presented at ASCO

By Ed Susman

NEW ORLEANS -- June 8, 2004 -- Patients with advanced, metastatic melanoma may achieve prolonged survival with a treatment combination of interferon a-2b and temozolomide, researchers said here on June 6th at the American Society of Clinical Oncology 40th Annual Meeting.

"This combination has antitumor activity in patients with advanced, unresectable malignant melanoma, including those with visceral metastases," said Lynne Lamb, RN, MSN, clinical research nurse, Memorial Sloan-Kettering Cancer Center, New York, New York.

In a poster presentation, Ms. Lamb said that the study specifically investigated patients who had no known brain metastases. While temozolomide is often prescribed for patients with brain metastases because the agent can cross the blood-brain barrier, she said, none of the patients in this study had brain lesions.

In a study led by Wen-Jen Hwu, MD, PhD, Study Chair, Department of Medicine, Memorial Sloan Kettering, Ms. Lamb and colleagues recruited 34 patients into the study. All of the subjects in the open-label, phase 2 study had unresectable stage III and stage IV metastatic melanoma with measurable disease.

The researchers decided to pair the 2 drugs because they noted that interferon a-2b "has some antitumor activity against melanoma, but has been used primarily at high, toxic doses. At low doses, interferon has anti-angiogenic activity, and has induced regression of life-threatening childhood hemangiomas. Pegylated interferon is better tolerated and more effective than conventional interferon in treating hepatitis C."

"We hypothesized that low-dose pegylated interferon might act additively or synergistically with the cytotoxic agent, temozolomide, in the treatment of malignant melanoma," Ms. Lamb added.

Temozomolide was administered orally at 75 mg/m² a day for 6 weeks, followed by a 2-week break. Pegylated interferon was administrated at.5 micrograms/kg by weekly subcutaneous injection for 8 weeks. The combination treatment did not create unacceptable toxicity, with no grade 4 toxicities reported; however, 26 of the patients did develop grade 2 or grade 3 lymphopenia.

Of the 34 patients, 15 have died and 19 remain alive at 2 to 29-plus months from study entry. Overall median survival is 9.7 months, Ms. Lamb said. One patient achieved a complete response, 9 achieved partial responses, and 3 patients have maintained stable disease

"The combination of temozolomide, given on an extended daily dosing schedule for 6 weeks, together with pegylated interferon a-2b given weekly by subcutaneous injection for 8 weeks, is generally safe and well tolerated in patients with advanced malignant melanoma without brain metastases."


[Presentation title: A Phase II Study of Temozolomide (TMZ) and Pegylated Interferon 2b (PGI) in the Treatment of Advanced Melanoma. Abstract 7533]

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